Method and device for defrosting blood plasma

FIELD: medicine; medical engineering.

SUBSTANCE: method involves dipping plastic bags containing blood plasma frozen to -25 - -30°C and lower, into bath filled with water to achieve full thaw at water temperature not exceeding 8°C or at 35-37°C washing the bags with turbulent flow. The bags are arranged in chessboard order and defrosting process is carried out as follows. First, the bags containing blood preparations are defrosted to 0-4°C. The temperature being achieved is determined from water level reduction in the bath to a calculated value determined from formula Δh = n(Vfp - Vlp)/S, (1), where Δh is the given value of water level reduction in the bath when thawing the plasma, n is the number of bags containing frozen plasma, placed in the bath at a time, Vfp is the frozen plasma bag volume, Vlp is the liquid plasma bag volume, S is the bath area. Timer is switched on for a calculated time applied to bring the bags containing blood components to 7-8°C. Device has bath filled with distilled water, heating and cooling device temperature sensor and control circuit as well as mixer having electric drive connected to executive circuit of the control circuit and water level sensor connected to control circuit input. The bath has canals for letting water flow from bath end to compartment where the mixer is placed. The mixer is separated from the rest objects in the bath with vertical partition communicating with the bath via connecting hole in the lower part of the compartment. The control circuit comprises the timer.

EFFECT: accelerated defrosting process.

2 cl, 2 dwg, 1 tbl

 

The invention relates to the field of medicine and biology, and in particular to methods and devices for thawing frozen blood products such as blood plasma, mainly with the purpose to receive cryoprecipitated antihemophilic factor,

Various methods and devices for the preparation of pharmaceutical preparations, including preparations of blood. It is known, for example, a device for the manufacture of medicinal solutions containing collections of distilled water and the filtrate is connected by a flexible pipe mixer, installation for filtering and node dosing, the timer for counting the time of mixing and the pressure gauge, and the mixer, made in the form of a cylindrical tank made of stainless steel, the top is closed hermetically by a cover, which made the nest to accommodate mixers, hatch to download the source of medicines and breathing filter, on the side of the mixer in the upper part attached two fittings for the supply of water and mud and water element and the window for illumination and visual observation of the dissolution of the original drug in the bottom of the mixer is mounted fitting for draining the prepared solution, the apparatus for filtering includes pumps and filter node, the node dosing, connected to the output settings for filtering, consists of stand base building, unit dosing, and drug vials, the device additionally introduced control unit mixer, includes remote control, electronic timer for timing the mixing solution, water element and node variable control of the number of revolutions of the shaft automatic stirrers made removable, propeller type with two heads on the same shaft and connected through the clutch with the motor connected to the control unit, mixer, site peristaltic pump installation for filtering comprising a pump head with a gearbox, the motor and the control unit of the pump, the filter Assembly installation for filtering includes a housing, a cap with gauge, the filter membrane and the pump with manual transmission, the dosing module node dosing is made in the form of a measuring cylinder placed in it by a floating piston, the two-way valve with an electromagnetic actuator and an electronic control unit nodes dosing, with the fitting of the mixer for the supply of the solution is connected to the pipe through the valve with the outlet of the pump and through the second gate node of the filter and the nozzle of the faucet to drain the prepared solution of the connected pipeline through the third valve to the pump installation for filtering (patent RU №2057521, class a 61 J 3/00, publ. 10.04.96 g, bull. No. 10).

<> A disadvantage of the known device is the lack of thermoregulation, which complicates the use of the device in cases where technological conditions required to maintain a specific temperature.

Closest to the claimed invention is freezer plasma MT-210 PLASMA THAWER OPERATOR''S MANUAL Rev. A" production company "TermoGenesis Corp." ("THERMO"), Canada, 1998, Specified defroster plasma includes camera defrost, top cover with flexible pockets, mechanical hand, a heating element, temperature controller, remote control, water supply fitting. Thawing plasma is produced from a temperature of -25 to +37°when the water temperature in the chamber thawing from 35 to 37°and the maximum amount of plastic bags with plasma is 10 PCs

The disadvantage of plasma freezer is that the water temperature is regulated in a very narrow interval (35÷37° (C)that does not allow you to use the freezer for selection of frozen blood plasma factor VIII, followed by centrifugation of the blood plasma at a temperature not more than +8°C.

There are also known methods of thawing plasma. Known, for example, the method of defrosting blood plasma, including the thawing of fresh frozen plasma at a temperature of 0÷+4°s to to the nsistency melted snow, followed by centrifuging the thawed plasma in a refrigerated centrifuge at a temperature of 0÷+2° (order No. 155 of the USSR Ministry of health from 12.04.90,, p "Cryoprecipitate").

The disadvantage of this method is the length of the thawing of plasma (up to 1.5 hours).

Closest to the claimed method of thawing plasma (prototype) is a method of thawing of blood plasma, including plastic dip packages frozen plasma (temperature -25÷-30°and below) in a special bath with water at a temperature of +6÷+8°until complete thawing ("production schedule production, "Cryoprecipitate", p. TA 2.3, p.25, 1997, reviewed and approved by the Commission on standardization of health Ministry 26.12.97, Protocol No. 86).

The disadvantage of this method is the length of the defrost period (up to 1.5 hours), which leads to decreased activity of factor VIII in cryoprecipitate, and that the end of the defrost is determined subjectively. Because packets with blood components may be at a different temperature range of -25° ÷ -40°From time to defrost temperature 0° ÷ +4°also changes in a wide range of values, which makes it difficult to automate the process.

Task group invention is the mouth of Annie mentioned disadvantages and to provide a method of quick thawing of plasma and device for quick thawing of plasma temperature -30° C to +8°with subsequent centrifugation to obtain factor VIII, which would maximize the activity of factor VIII in one dose cryoprecipitate (more than 100 international units), or to a temperature of +35÷+37°With subsequent administration to patients with hemophilia or von Willebrand's disease, as well as for bleeding other etiology.

The problem is solved by the proposed group of inventions containing methods for thawing plasma, comprising immersing plastic bags of frozen -25÷-30°With plasma in a bath of distilled water at a temperature not higher than +8°until complete thawing, and bags of plasma immersed in a bath in a checkerboard pattern, the defrosting is carried out at the turbulent flushing bags and the value of the Reynolds criterion more than 10,000 first bags of thawed plasma to 0° ÷ +4°With, on reaching this temperature is judged by the amount of Δh - reduction of water level in the tub during thawing of plasma, which is calculated by the formula:

where

Δh - set value of the reduction in water level in the tub during thawing plasma, determined empirically, n is the number of bags of frozen plasma, placed in a bath at once, VRFP- the volume of a bag of frozen (solid) plasma, Vha/sub> - the volume of the bag with the melted (liquid) plasma, S - area of the bath, the calculated value Δh set the sensor is triggered, then include a timer for counting the time required to bring the temperature of bags to +7 ÷ 8°C.

This method is implemented using a device for thawing plasma comprising bath with distilled water, heating and cooling devices, temperature sensor and control circuit, and a mixer with electric included in the Executive chain of the control circuit, the sensor of the liquid level in the tub, connected to the input control circuit, a tub provided with channels for the flow of fluid from the end of the bath into the Bay, where the stirrer, the stirrer is separated from the rest of the volume of the bath wall with holes, bath equipped with a grid to position the bags of plasma in a checkerboard pattern, with the evaporator of the cooling and heating device are directly in the bath, the liquid level sensor placed in the bath compartment, separated from the rest of the volume by vertical partitions and soobshayem with bath through the connecting hole in the lower part of the compartment, and the control scheme introduced timer.

The proposed group of inventions is illustrated in the drawings, in which figure 1 is a schematic diagram device is istwa for thawing plasma, figure 2 is a top view of the proposed device.

Device for thawing plasma (1, 2) includes bath 1, made of stainless steel, partition 2 with holes, separating the mixer 3 from the main volume 4 baths, heating element 5 located on the bottom of the bath 1, a cooling unit (evaporator) 6, also located on the bottom of the bath, grating holder 7 for the location of the bags 8 frozen plasma in a checkerboard pattern, and the sensor 9 of the liquid level, is placed in the compartment 10, which is separated from the main volume 4 bath 1 by vertical partitions 11 and soobshayem volume 4 through the connecting the hole 12 in the lower part of the compartment 10. The rotation of the stirrer is supplied from the actuator 13 by the control circuit 14. To ensure the flow of water to the mixer 3 from opposite walls of the tub are the channels 15 formed by vertical partitions 16 arranged parallel to the side walls of the bath 1. On and off switching elements 5 and 6 is performed by the control circuit 14 from the temperature sensor 17, which automatically maintains the water temperature within the given interval. Control circuit 14 includes a timer (not shown).

The method of thawing plasma by means of the described device is as follows. Take out of freezer plastic is nye bags 8 frozen plasma at a temperature of -25÷ -30°C and below. Pour into the tub 1 distilled water having a room temperature. Include the control circuit 14 and by means of the elements 5 and 6 bring the water temperature to the preset value (+7 ÷ +8°or +35÷+37°). Immersed in a bath 1, for example, 20 plastic bags 8 with plasma. When the water level in the tub rises, and the water temperature decreases, and the control circuit 14 maintains the desired temperature of the water in the tub using elements 5 and 6. Then build the sensor 9 of the liquid level a decrease in the water level in the tub Δh, calculated by the formula (1). In order to intensify the process of thawing the plasma and reduce the time defrost by creating in the tub turbulent flow, used mixer 3 with the actuator, which is separated by a partition 2 with holes from the main volume 4 baths, which are bags with 8 plasma. The last is placed in the holder 7 in a checkerboard pattern. The holder 7 is made of a lattice (mesh) stainless wire and serves not only to accommodate bags 8 in this order, but also prevents you from moving the bags in the bath under the action of turbulent water jets generated by the mixer 3. In order to speed up the process of temperature regulation, the heating element 5 and the cooling element 6 placed directly the public in the bath 1 under bags 8. For the formation of turbulent jets is partition 2 with holes, ensuring the achievement of the criterion Re >10000. This value of the Reynolds criterion and the flow velocity of the water in the tub 1 is provided by controlling the number of revolutions of the mixer 3 and the availability of channels 15, which provides the flow of water from the volume of water 4 to the mixer. In order to improve the accuracy of water level and time of a timer, a sensor 9 liquid level is placed in the compartment 10, which is separated from the volume 4 baths 1 partitions 11, but it is reported volume 4 through the connecting hole 12. With this in compartment 10, the water level is not exposed to fluctuations in the rotation of the agitator 3 and flowing from volume 4 on channels 15. It was found experimentally that when thawed standard plastic bag with plasma from the initial temperature -30÷-40°With temperatures of 0÷+4°its volume is reduced by 12-15%. Based on the ratio of the volume of the bath 1 and the total volume of thawed bags 8 by the formula (1) is determined by the magnitude of the decline in water level Δh in the tub when thawed blood components to a temperature of 0÷+4°at this size Δh and set the trigger level sensor 9. When the water level drops to a predetermined value, this would mean that the plasma in bags razmorozili to temperature is 0÷ +4°C. At this point, the sensor 9 will signal to switch on the timer. The timer starts counting the estimated time to bring the temperature of bags 8 to +7÷8°With (if thawed plasma for subsequent centrifugation and receiving factor VIII), or to +35÷37°With (for patient with hemophilia or von Willebrand's disease). The specified time can be defined, for example, empirically. After a predetermined time, the timer will signal the staff (call) about the end of the thawing process. The described method of thawing of blood components can be used in laboratory, clinical and industrial environments. The number of bags of blood plasma can vary from 1 to 20 depending on the needs, and heat the bags can be made up to any desired temperature from 0 to +37°With the minimum time.

The described method of thawing plasma and device for its implementation make it possible to reduce the time of thawing of plasma (up to 15-20 minutes)that provides improved performance and quality of cryoprecipitate, and also allows you to automate the process of defrosting. To assess the quality of thawed according to the invention, the plasma was carried out comparative tests with the method of defrosting the prototype (plasma were restoratives until the temperature is s +8° C). The results are given in the table.

IndicatorsThe proposed group of inventionsThe placeholder
123
The number of bags of plasma20 PCs20 PCs
Time defrosting16 minutes51 minutes
The activity of factor VIII in one dose cryoprecipitate140-180 international units100-150 international units

Thus, from the above table it can be seen that reducing the time of thawing of the plasma is about 3 times can significantly increase the activity of factor VIII in cryoprecipitate.

The proposed group of inventions can reduce the time of thawing of plasma about 3 times, increase productivity, improve the quality of cryoprecipitate, to automate the process of thawing the plasma to extend the functionality of the device for thawing plasma.

1. The method of thawing plasma, comprising immersing plastic bags of frozen -25÷-30°With plasma in a bath of distilled water at a temperature not higher than +8°until complete thawing, characterized in that the bags PLA is my immersed in a bath in a checkerboard pattern, defrosting is carried out at the turbulent wash bags and the value of the Reynolds criterion more than 10,000 first bags of thawed plasma to 0° ÷ +4°With, on reaching this temperature is judged by the amount of Δh - reduction of water level in the tub during thawing of plasma, which is calculated by the formula:

,

where Δh - set value of the reduction in water level in the tub during thawing plasma determined empirically;

n - number of bags of frozen plasma, placed in a bath at one time;

VRFP- the volume of a bag of frozen plasma;

Vha- the volume of the bag with liquid plasma;

S - size bath,

the calculated value Δh set the sensor is triggered, then include a timer for counting the time required to bring the temperature of bags to +7° ÷ 8°C.

2. Device for thawing plasma comprising bath with distilled water, heating and cooling device, a temperature sensor, a control circuit, characterized in that it contains a mixer with electric included in the Executive chain of the control circuit, the sensor of the liquid level in the tub, connected to the input control circuit, a tub provided with channels for the flow of fluid from the end of the bath the compartment, where the stirrer, the stirrer is separated from the rest of the volume of the bath wall with holes, bath equipped with a grid to position the bags of plasma in a checkerboard pattern, with the evaporator of the cooling and heating device are located directly in the bath, the liquid level sensor placed in the bath compartment, separated from the rest of the volume by vertical partitions and communicating with the tub through the connecting hole in the lower part of the compartment, and the control scheme introduced timer.



 

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